Typically, the vagina of a healthy human female has a pH of less than 4.5. It is well known that an elevated pH occurs among women with a variety of bacterial infections. Determining the pH level of the vagina is usually done by a doctor or clinician in a doctor's office because false readings are easily obtained if the procedure is not carried out properly, e.g., if the pH paper used comes in contact with outer vaginal secretions, cervical secretions or urine. Such contact can yield false pH readings in the high range, possibly provoking an unnecessary visit to a doctor's office, or in the low range, urine contamination which could yield a false negative response and a delay in treatment with potentially serious consequences.
There are few, if any, self-testing devices presently in use as a result of this contamination problem. Accordingly, it would be advantageous to provide a reusable vaginal testing applicator assembly which would minimize the hazard of obtaining false readings through contact with contaminating substances.
The patent literature includes body cavity testing apparatus in which a treated or test paper, such as pH paper, has been employed to determine fertility and/or ovulation. Thus, U.S. Pat. Nos. 2,945,491, 3,017,897, 3,037,496 and 3,117,569 are all examples of applicator or test apparatus which has been used to test for fertility or ovulation. In each of these patents, an instrument is provided for insertion of the test paper into the body cavity, in this case, the vagina, so that the paper can be contacted with bodily fluids to conduct a test of the condition of the fluids in the vagina.
In U.S. Pat. Nos. 2,945,491 and 3,117,569, the testing paper is affixed to the end of the applicator or instrument body and is not capable of being shielded during insertion or removal from the vagina. In U.S. Pat. Nos. 3,017,879 and 3,037,496, the treated papers or testing members can be retracted into the housing of the applicator bodies so as to shield the same during insertion and removal from the vagina. Thus, the test paper tends not to become contaminated by vaginal secretions or urine during the insertion and removal processes.
One problem which has been encountered in connection with such vaginal secretion testing apparatus is that the test paper or treated test material can become overwhelmed by the bodily fluids. This is particularly true when bacterial infections are present. The test paper or material, therefore, can loose its mechanical integrity and/or yield false readings as a result of the excess fluids. Moreover, while trained physicians can develop and perfect their testing techniques was to try to minimize the possibility of contamination, unskilled users when attempting self-testing may not fully retract the test paper during insertion and removal.
U.S. Pat. No. 2,664,879 discloses a similar body testing apparatus in which pH paper can be inserted into a body cavity, such as the vagina, and the test paper compared to a color chart once a specimen has been contacted with the paper. Again, the primary problem with such apparatus is that there is no shielding of the test paper, and the paper can be easily overwhelmed by bodily fluids.
The use of comparison charts or test strips in connection with medical diagnostic apparatus is broadly known in the prior art. Thus, U.S. Pat. Nos. 3,272,319, 3,507,269, 3,552,929, 3,572,997 and 3,990,850 are all examples of biological testing apparatus in which the effect of a test specimen on a test material is compared to a known chart or strip. Such comparison allows a match between the unknown test sample and the known chart colors to enable a diagnosis to be made.
Accordingly, it is an object of the present invention to provide a body cavity specimen collecting and testing apparatus and method which can be easily used by untrained personnel for self-testing of the condition of fluids in a body cavity.
Another object of the present invention is to provide a body cavity specimen collecting and testing apparatus and method which has improved reliability and will not be overwhelmed by an excess of bodily fluids.
Still further an object of the present invention is to provide a vaginal specimen collecting and testing apparatus which is simple and inexpensive to construct and is easy to use.
The body cavity specimen collecting and testing apparatus of the present invention has other objects and features of advantage which will become apparent from or are set forth in more detail in the following description of the best mode of carrying out the invention and the accompanying drawing.